Biotie to regain global rights to tozadenant from UCB

March 21, 2014 02:00 ET | Source:Biotie Therapies

BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 21 March 2014 at 8.00
a.m.
Biotie to regain global rights to tozadenant from UCB
* Tozadenant is transitioning into Phase 3 development for Parkinson's
disease
* Biotie to host a conference call for analysts and media today at 14:00
Central European time
Turku, Finland, March 21, 2014. Biotie Therapies Corp. announced today that UCB
Pharma S.A. (UCB) will return global rights to tozadenant to Biotie. Tozadenant
(SYN115), a selective inhibitor of the adenosine 2a (A2a) receptor, has
delivered clinically relevant and statistically highly significant effects in
Parkinson's disease, across multiple pre-specified evaluation parameters, in a
420 patient Phase 2b study completed in December 2012. Tozadenant is expected to
start recruitment for the Phase 3 program in H1 2015.
Biotie regaining the rights follows after UCB's assessment of its early and late
stage clinical development pipeline as well as its preclinical opportunities and
does not reflect any concerns regarding safety or efficacy of tozadenant.
"We respect UCB's portfolio based decision, and appreciate its significant
investment and commitment to the tozadenant program to-date. Owning full global
rights to tozadenant will enable Biotie to evaluate the most suitable
development strategy for this Phase 3 ready asset to maximize its value to our
shareholders. As part of this evaluation we will consider other partners to
assist us in the development and commercialization of this novel compound. We
remain convinced that tozadenant will provide significant and clinically
meaningful benefits to Parkinson's patients based on the robust and positive
Phase 2b data, that we have already reported", says Timo Veromaa, President and
CEO of Biotie.
"At UCB, we have a very rich portfolio of research and development programs and
continuously review and prioritize within the portfolio", says Prof. Dr. Iris
Loew-Friedrich, CMO of UCB. "We will continue working with Biotie to make
tozadenant phase 3 ready and to ensure a smooth transition of the program back
to Biotie."
UCB has confirmed that it will meet all its contractual and scientific
commitments regarding the ongoing development program for tozadenant, including
conducting together with Biotie the scheduled End-of-Phase 2 meeting with US
Food and Drug Administration in H1 2014. The companies are working together to
execute an appropriate transfer of the program back to Biotie.
Tozadenant was originally licensed to UCB in 2010 and UCB paid Biotie $20
million to exercise its license in February 2013.
Biotie expects to be able to give further guidance on any potential change in
development timelines during Q2 2014.
Turku, 21 March 2014
Biotie Therapies Corp.
Timo Veromaa
President and CEO
Conference call
An analyst and media conference call will take place on Friday, 21 March 2014 at
14:00 Central European Time, 15:00 Finnish Time. The conference call will be
held in English.
Lines are to be reserved ten minutes before the start of conference call. The
event can also be viewed as a live webcast at www.biotie.com. An on demand
version of the conference will be published on Biotie's website later during the
day
Telephone conference numbers:
US callers: +1646 254 3362
UK callers: +44(0)20 3427 1906
Finnish callers: +358(0)9 6937 9590
Access code: 3535680
In case you need additional information or assistance, please contact: Virve
Nurmi, IR Manager, Tel: +358 2 2748 911
For further information, please contact:
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, virve.nurmi@biotie.com
David Dible, Citigate Dewe Rogerson
Tel +44 207 282 2949, david.dible@citigatedr.co.uk
Distribution:
NASDAQ OMX Helsinki Ltd
Main Media
About tozadenant
Tozadenant is an oral, potent and selective adenosine A2a receptor antagonist
being developed for the treatment of Parkinson's disease. Tozadenant has
displayed clinically relevant and statistically highly significant effects in
Parkinson's disease, across multiple pre-specified evaluation metrics, in a 420
patient Phase 2b study completed in December 2012, and it is currently
transitioning into Phase 3 development.
The preparations for the tozadenant Phase 3 program in Parkinson's disease have
progressed well. These activities include CMC and non-clinical work, and certain
Phase 3 enabling clinical pharmacology studies.
About Biotie
Biotie is a specialized drug development company focused on products for
neurodegenerative and psychiatric disorders. For the past years, Biotie has
successfully operated a strategy built around search, profile and partner. This
has delivered Selincro (nalmefene) for alcohol dependence, which received
European marketing authorization in February 2013 and is currently being rolled
out across Europe by partner H. Lundbeck A/S, and tozadenant, a novel A2a
antagonist which is transitioning into Phase 3 development for Parkinson's
disease and for which Biotie holds exclusive, global rights. Biotie is actively
developing its pipeline assets, including SYN120, a unique potent 5-HT6/5-HT2a
dual antagonist for which a Phase 2 study in Alzheimer's diseases is expected to
commence recruitment by the end of 2014; nepicastat, a selective inhibitor of
dopamine beta hydroxylase which is currently in a Phase 2 study, fully funded by
NIDA, for treatment seeking cocaine addicts and for which topline data is
expected in the first half of 2015; and BTT-1023, a monoclonal antibody
targeting Vascular Adhesion Protein 1 for which a Phase 2 study in primary
sclerosing cholangitis, a rare fibrotic disease of the liver, is expected to
start recruiting by the end of 2014. Biotie's shares are listed on NASDAQ OMX
Helsinki.
www.biotie.com
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